Webinar
Medical Devices

Understanding Article 61 (10)

This webinar will elaborate on BSI’s understanding of when it is appropriate to claim that no clinical data is required for clinical evaluation.

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This webinar:

The MDR requirements around Article 61 (10).
What data can be used to support Article 61 (10).
Examples of devices suitable for Article 61 (10).
Considerations for the CER and Article 7 claims.

Speakers

Hear from the experts in this webinar

Speaker

Richard Holborow

Head of Clinical Compliance, BSI

Insights & Media

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